FDA 510(k) Application Details - K013884

Device Classification Name	Attachment, Breathing, Positive End Expiratory Pressure   More FDA Info for this Device
510(K) Number	K013884
Device Name	Attachment, Breathing, Positive End Expiratory Pressure
Applicant	VYGON S A 45900 PARSIPPANY COURT TEMECULA, CA 92592 US Other 510(k) Applications for this Company
Contact	LAETITIA BERNARD Other 510(k) Applications for this Contact
Regulation Number	868.5965   More FDA Info for this Regulation Number
Classification Product Code	BYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2001
Decision Date	01/21/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review